Salbutamol Sandoz 100 microgramsdose pressurised inhalation

Land: Maleisië

Taal: Engels

Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Werkstoffen:

SALBUTAMOL SULPHATE

Beschikbaar vanaf:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Algemene Internationale Benaming):

SALBUTAMOL SULPHATE

Eenheden in pakket:

1units Units

Geproduceerd door:

AEROPHARM GMBH

Bijsluiter

SALBUTAMOL SANDOZ PRESSURISED
INHALATION
Salbutamol (100 micrograms/actuation)
1
_Consumer Medication Information Leaflet (RiMUP) _
WHAT IS IN THIS LEAFLET:
1.
What Salbutamol Sandoz MDI is
used for
2.
How Salbutamol Sandoz MDI works
3.
Before you use Salbutamol Sandoz
MDI
4.
How to use Salbutamol Sandoz MDI
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
Salbutamol Sandoz MDI
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT SALBUTAMOL SANDOZ MDI IS USED
FOR
Salbutamol Sandoz is used to treat
asthma. It can also be used to prevent
asthma caused by exercise or asthma
caused by a reaction to allergens
(substances to which you are allergic to
e.g. house dust, pollen, dog hair, cat hair,
cigarette smoke, etc.) or to treat breathing
difficulties associated with reversible
airways obstruction (e.g. chronic
bronchitis).
This type of medicine is known as a
‘reliever’. You may be using another
medicine to prevent you from having an
asthma attack (“preventer”). You can
safely use your preventer with this
medicine.
HOW SALBUTAMOL SANDOZ MDI WORKS
Salbutamol expands the airways, allowing
the air to flow more freely. Salbutamol
should primarily be used to relieve
symptoms rather than as a regular treatment.
BEFORE YOU USE SALBUTAMOL SANDOZ
MDI
-
_When you must not use it _
•
if you are allergic (hypersensitive) to
salbutamol sulphate or any of the
other ingredients of Salbutamol.
-
_Before you start to use it _
Ask your doctor for advice before using
Salbutamol, if any of the following
conditions apply to you:
•
severe heart disease
•
severe and untreated high blood
pressure
•
enlarged artery (aneurysm)
•
diabetes (extra checks of blood
glucose levels are recommended
when beginning treatment with
Salbutamol)
•
tumour of the adrenal medulla
(pheochromocytoma). The adrenal
medulla are two glands situated above
the kidneys.
•
an overactive thyroid gland
•
too little potassium in the blood
_PREGNANCY AND BREAST-FEEDING _
Limited knowledge

Productkenmerken

PACKAGE INSERT
1.
NAME OF THE MEDICINAL PRODUCT
Salbutamol Sandoz 100 micrograms/dose pressurised inhalation.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One metered dose contains 120 micrograms of salbutamol sulphate
equivalent to 100 micrograms of
salbutamol.
The delivered dose through the mouthpiece contains 108 micrograms of
salbutamol sulphate equivalent to
90 micrograms of salbutamol (as sulphate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Preparation for inhalation in form of pressurised metered-dose
inhaler.
Pressurised inhalation, white suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic relief of bronchospasm in bronchial asthma and in other
respiratory conditions.
Prophylaxis of exercise and allergen induced asthma.
Salbutamol is particularly useful for the relief symptoms of asthma,
providing it does not delay the
introduction and regular use of inhaled corticosteroid therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Salbutamol Sandoz is intended for inhalation only.
For relief of acute episodes of bronchospasm
Adult: 1 to 2 inhalations every four hours as necessary to obtain
relief of bronchospasm up to maximum of
8 inhalations per day. If dose at this rate is not effective or if
previously effective doses do not provide relief,
other treatment should be instituted promptly.
Children: As for adults.
Elderly: Dosage should at first be lower than for younger adults but
may be increased gradually to the
usual adult level if necessary.
To prevent allergen- or exercise-induced bronchospasm
Adults: 2 inhalations should be taken 10-15 minutes before challenge.
Children: 1-2 inhalations should be taken 10-15 minutes before
challenge.
Method of administration
_Handling _
A faulty inhalation technique with pressurised inhalers is very
common. It is therefore important that the
patient be instructed in the correct inhalation technique. The
patient’s inhalation technique should be
checked at visits.
Salbutamol Sandoz may be used with a Vortex
®
or AeroCh